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PMA P120019S016

Device
cobas EGFR Mutation Test v2
Applicant
Roche
PMA number
P120019
Supplement
S016
Product code
OWD
Decision date
2018-04-18
Classification
Somatic Gene Mutation Detection System
Generic name
Somatic gene mutation detection system
Approval order statement
Approval of the cobas® EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO® (osimertinib) Exon 19 deletions, L858R, and T790M T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.*The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2. Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, Exon 20 insertions, T790M, S768I, and L861Q G719X, Exon 20 insertions, T790M, S768I, and L861QTAGRISSO® (osimertinib) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 19 deletions, L858R, Exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.

Current openFDA PMA Record#

Device
cobas EGFR Mutation Test v2
Applicant
Roche
PMA number
P120019
Supplement
S016
Product code
OWD
Generic name
Somatic gene mutation detection system
Decision date
2018-04-18
Decision code
APPR
Date received
2017-10-27
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval of the cobas® EGFR Mutation Test v2. The device is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or circulating-free tumor DNA (cfDNA) from plasma derived from EDTA anti-coagulated peripheral whole blood. The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 below in accordance with the approved therapeutic product labeling:Table 1Drug FFPET PlasmaTARCEVA® (erlotinib) Exon 19 deletions and L858R Exon 19 deletions and L858RTAGRISSO® (osimertinib) Exon 19 deletions, L858R, and T790M T790M*Patients with positive cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of the EGFR mutations listed above are eligible for treatment with the corresponding drug as indicated in Table 1 (see Note* for T790M). Patients who are negative for these mutations by this test using plasma specimens should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.*The efficacy of TAGRISSO (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas® EGFR Mutation Test v2. Table 2Drug FFPET PlasmaTARCEVA® (erlotinib) G719X, Exon 20 insertions, T790M, S768I, and L861Q G719X, Exon 20 insertions, T790M, S768I, and L861QTAGRISSO® (osimertinib) G719X, Exon 20 insertions, S768I, and L861Q G719X, Exon 19 deletions, L858R, Exon 20 insertions, S768I, and L861QFor manual sample preparation, FFPET specimens are processed using the cobas® DNA Sample Preparation Kit and plasma specimens are processed using the cobas® cfDNA Sample Preparation Kit. The cobas z 480 analyzer is used for automated amplification and detection.